[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561845":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":44,"locations":53,"responsibleParty":70,"collaborators":72,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":27,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":27,"enrollmentInfo":87,"targetDuration":27,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":27,"overallStatus":56,"whyStopped":27,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University of Wisconsin, Madison","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"3mg Nicotine Pouches","EXPERIMENTAL","Participants will use 3mg nicotine pouches",[13],"Drug: Nicotine Pouches",{"label":15,"type":10,"description":16,"interventionNames":17},"6mg Nicotine Pouches","Participants will use 6mg nicotine pouches",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Nicotine Mini Lozenges","Participants will use mini lozenges with dosing based on time to first cigarette (2mg or 4mg)",[22],"Drug: Mini Nicotine lozenges",{"label":24,"type":25,"description":26,"interventionNames":27},"No Study Product","NO_INTERVENTION","Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.",null,[29,36],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Nicotine Pouches","nicotine pouches",[9,15],[35],"ZYN",{"type":30,"name":37,"description":38,"armGroupLabels":39,"otherNames":27},"Mini Nicotine lozenges","mini lozenges",[19],[41],{"name":42,"affiliation":5,"role":43},"Megan Piper, PhD","PRINCIPAL_INVESTIGATOR",[45,49],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},"CONTACT","608-265-5472","mep@ctri.wisc.edu",{"name":50,"role":46,"phone":51,"phoneExt":27,"email":52},"Mark Zehner","608-262-7568","mark.zehner@wisc.edu",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of Wisconsin","RECRUITING","Madison","Wisconsin","53705","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-89.40123,43.07305,{"lat":66,"lon":65},[69],{"name":42,"role":46,"phone":47,"phoneExt":27,"email":48},{"type":71,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[73,76],{"name":74,"class":75},"National Institutes of Health (NIH)","NIH",{"name":77,"class":75},"National Cancer Institute (NCI)","100561845","phase-4-the-options-2-study-100561845",false,"NCT06595459","The Options 2 Study","A Randomized Comparative Effectiveness Trial of Nicotine Pouches for Cigarette Substitution: A Question of Public Health","Inclusion Criteria:\n\n* ≥ 21 years old (i.e., able to legally purchase tobacco products)\n* able to read and communicate in English\n* no plans to quit smoking in the next 30 days\n* willing to stop using nicotine replacement or varenicline\n* willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation\n* smoking ≥ 5 cigarettes per day for the past 6 months\n* exhaled carbon monoxide ≥ 6 ppm\n* no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months\n\nExclusion Criteria:\n\n* currently in treatment for psychosis or bipolar disorder\n* currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)\n* currently pregnant or breastfeeding","ALL","21 Years",{"count":88,"type":89},300,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products.\n\nParticipants will:\n\n* Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks.\n* Have 6 in-person research visits and 1 follow-up call\n* Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use",[95,96],"Smoker","Smoking Cessation","2026-06-17",{"date":99,"type":100},"2026-06-22","ACTUAL",{"date":102,"type":100},"2025-05-21",{"date":104,"type":89},"2029-07-30",{"name":5,"class":6},1]